A Study of Investigational Tirzepatide (LY3298176) Doses in Participants With Type 2 Diabetes and Obesity

Phase 2

Recruiting

• Conditions: Obesity; Type 2 Diabetes

• Registration Number: NCT06037252
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-9-8
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

Inclusion Criteria<br><br> - Have a Body Mass Index (BMI) =35 kilogram/square meter (kg/m²) at screening.<br><br> - Have had stable body weight (±5%) during the 90 days preceding screening.<br><br> - Have been diagnosed with Type 2 Diabetes (T2D).<br><br> - Have been on a stable treatment of metformin only at least 90 days preceding<br> screening and between screening and randomization with the minimum effective dose of<br> =1500 milligram (mg)/day.<br><br>Exclusion Criteria:<br><br> - Have Type 1 Diabetes (T1D), history of ketoacidosis or hyperosmolar state/coma, or<br> any other types of diabetes except T2D.<br><br> - Have had 1 or more episode of severe hypoglycemia and/or 1 or more episode of<br> hypoglycemia unawareness within 6 months prior to screening.<br><br> - Are currently receiving or planning to receive treatment for diabetic retinopathy<br> and/or macular edema.<br><br> - Have a prior or planned surgical treatment for obesity.<br><br> - Use products intended for weight loss including prescription drugs, over the counter<br> (OTC) drugs, and herbal preparations, within 3 months prior to screening.<br><br> - Have renal impairment measured as estimated glomerular filtration rate (eGFR) <45<br> milliliter/min (mL/min)/1.73 m².<br><br> - Have any of the following cardiovascular (CV) conditions within 2 months prior to<br> screening.<br><br> - acute myocardial infarction.<br><br> - cerebrovascular accident (stroke).<br><br> - unstable angina .<br><br> - hospitalization due to congestive heart failure, or<br><br> - coronary artery revascularization.<br><br> - Have a family or personal history of medullary thyroid carcinoma or multiple<br> endocrine neoplasia (MEN) syndrome Type 2.<br><br> - Have a history of chronic or acute pancreatitis.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Body Weight

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in HbA1c;Change from Baseline in HbA1c;Percent Change from Baseline in Body Weight;Absolute Change from Baseline in Body Weight;Absolute Change from Baseline in Body Weight;Change from Baseline in Body Mass Index (BMI);Change from Baseline in BMI;Change from Baseline in Waist Circumference;Change from Baseline in Waist Circumference;Percentage of Participants Achieving =15% Body Weight Reduction;Percentage of Participants Achieving =15% Body Weight Reduction;Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC)